Bioimpedance Analysis Guided Volume Expansion for the Prevention of Contrast Induced-acute Kidney Injury

X-ray Contrast Media Adverse Reaction Clinical Trial

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Official title:

Bioimpedance Analysis Guided Volume Expansion for the Prevention of Contrast

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02449317
• Other study ID #: 2558/171
• Status: Completed
• Phase: N/A
• First received: May 17, 2015
• Last updated: August 31, 2017
• Start date: May 2015
• Est. completion date: January 2016

Study information

• Verified date: August 2017
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bioelectrical impedance analysis guided volume expansion for the prevention of contrast induced-acute kidney injury

Description:

Compared bioelectrical impedance analysis guided hydration therapy versus standard hydration for the prevention of contrast induced-acute kidney injury

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age 18-90 yr

2. Chronic kidney disease stage 3 & 4 (eGFR 15-60 ml/min/m2)

3. elective cardiac catheterization

Exclusion Criteria:

1. Contrast media administration in the past 14 days

2. congestive heart failure (NYHA III-IV, ascites , pleuropericardial effusion ,severe valvular heart disease

3. Kidney transplant status or RRT

4. Emergency cardiac catheterization

5. Allergy to radiographic contrast media

6. Unstable renal function (change in serum creatinine = 0.5 mg/dl or 25% within 14 days prior to the study

7. Not inform consent

8. left ventricular ejection fraction < 40 %

9. Liver cirrhosis child B or C

10. Dosage of angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker changed in past 2 wk

Related Conditions & MeSH terms

• Acute Kidney Injury
• X-ray Contrast Media Adverse Reaction

Intervention

Other:
• Bioimpedance guided
bioelectrical impedance analysis guided hydration therapy : 7.5% Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV in 6 hours rate was adjusted regarding to extracellular water/total body water extracellular water/total body water < 0.36 : 4 ml/kg/hr extracellular water/total body water 0.36-0.4 : 2 ml/kg/hr extracellular water/total body water > 0.4 : 1 ml/kg/hr
• standard hydration
standard hydration : 7.5%Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV 1 ml/kg/hr in 6 hours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum creatinine at 48-72 hours after contrast administration	Acute kidney injury	48-72 hr
Secondary	serum creatinine at 2 weeks after contrast administration	Renal replacement therapy	2 weeks